A Study of FOLFIRINOX Drug Combination Before Surgery Compared to Immediate Surgery in Patients with Resectable Pancreatic Head Cancer

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What is this study about?

This study focuses on resectable pancreatic head cancer, which is a type of cancer that can be surgically removed from the head of the pancreas. The study evaluates whether giving chemotherapy before surgery (called neoadjuvant treatment) combined with standard treatment can improve patient outcomes compared to standard treatment alone.

The treatment involves several chemotherapy medications: fluorouracil, gemcitabine, irinotecan, capecitabine, oxaliplatin, and calcium folinate. Most of these medications are given through an infusion into a vein, while capecitabine is taken as an oral medication. The treatment period may last up to six months.

The study compares two different approaches: one group receives chemotherapy before surgery followed by standard treatment (surgery and additional chemotherapy), while the other group receives the standard treatment only (surgery followed by chemotherapy). The goal is to determine if giving chemotherapy before surgery can help reduce early deaths and help patients live longer overall.

1 Initial treatment assignment

After joining the study, you will be randomly assigned to one of two treatment groups: either neoadjuvant chemotherapy followed by surgery, or immediate surgery

The assignment is random and cannot be chosen by you or your doctor

2 Neoadjuvant chemotherapy group treatment

If assigned to the neoadjuvant group, you will receive chemotherapy before surgery

The chemotherapy combination (called FOLFIRINOX) includes the following medications:

– Fluorouracil given by infusion

– Irinotecan given by infusion

– Oxaliplatin given by infusion

– Calcium folinate given by infusion

– Capecitabine taken by mouth

3 Surgery

You will undergo surgery to remove the tumor in the head of the pancreas

The operation will be performed regardless of which treatment group you are in

After surgery, your recovery will be monitored for 90 days to check for any complications

4 Post-surgery chemotherapy

Following surgery, you will receive additional chemotherapy treatment

The medications used will be the same as in the pre-surgery chemotherapy

Your response to the treatment will be monitored throughout this period

5 Follow-up period

Your health status will be monitored for at least 18 months after starting the study

Regular check-ups will assess your overall health and recovery

Your quality of life will be evaluated during this period

Who Can Join the Study?

Must be at least 18 years old and healthy enough to undergo major surgery
Must have a tumor in the pancreatic head that can be surgically removed (resectable) and is likely to be pancreatic adenocarcinoma based on imaging tests
The cancer must be classified as T1-3, Nx, M0, which means:
– The tumor can be of various sizes (T1-3)
– The lymph node status may be unknown (Nx)
– There is no spread to other parts of the body (M0)
Must be physically able to receive chemotherapy treatment as part of the study
Must be willing and able to provide written informed consent to participate in the study
Both men and women can participate in the study

Who Cannot Join the Study?

Age below 18 years or above 75 years
Presence of metastatic disease (cancer that has spread to other parts of the body)
Previous chemotherapy or radiation therapy for pancreatic cancer
Presence of other active cancers
Severe heart conditions that would make surgery risky
Liver dysfunction (poor liver function)
Renal insufficiency (poor kidney function)
Pregnancy or breastfeeding
Inability to understand and sign informed consent
Serious medical conditions that could interfere with study participation
Immunodeficiency (weakened immune system)
History of severe allergic reactions to chemotherapy drugs
Mental health conditions that could affect compliance with study procedures
Participation in other clinical trials within the past 30 days
Inability to follow study procedures or attend follow-up visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Karolinska University Hospital	Solna	Sweden
Norrlands University Hospital	Umea	Sweden
Upwrojojew ox Gfwgpplrmt avs Sdtlijspmfd Uaqcdcynaf Hlktppko (pyy	Gothenburg	Sweden
Lverubqsqs Uptrqbhlsli	Linkoping	Sweden
Srxoe Uyjzboxldy Hlmpebjr	Malmo	Sweden

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.02.2017
Sweden	Recruiting	01.02.2017

Trial locations

Investigated drugs:

FOLFIRINOX is a combination chemotherapy treatment that contains multiple medications working together to fight pancreatic cancer. It includes folinic acid, fluorouracil, irinotecan, and oxaliplatin. This treatment is used before surgery (neoadjuvant therapy) to help shrink the tumor and make surgery more effective. It can help improve the chances of successful tumor removal.

Adjuvant chemotherapy refers to the standard chemotherapy treatment given after surgery to kill any remaining cancer cells and reduce the risk of cancer coming back. In this trial, it is used as part of the standard treatment approach.

Both treatment approaches in this trial (neoadjuvant FOLFIRINOX followed by surgery and adjuvant chemotherapy, versus immediate surgery followed by adjuvant chemotherapy) are being compared to determine which sequence provides better outcomes for patients with pancreatic head cancer.

Investigated diseases:

Pancreatic carcinoma

Pancreatic Head Cancer – A specific type of cancer that develops in the head portion of the pancreas, which is the widest part of this organ located closest to the small intestine. The disease begins when cells in the pancreatic head start growing uncontrollably, forming a tumor mass. As the cancer progresses, it can affect the function of the pancreas, which normally produces digestive enzymes and hormones like insulin. The tumor can potentially grow large enough to affect nearby structures, including the common bile duct and duodenum. This cancer typically develops gradually, and in its early stages, it may not cause noticeable symptoms.

Trial ID:

2024-517719-65-00

Protocol code:

NORPACT-1

NCT ID:

NCT02919787

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of FOLFIRINOX Drug Combination Before Surgery Compared to Immediate Surgery in Patients with Resectable Pancreatic Head Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?